Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008061617

FEI Number

3008061617

Entity Name

AMBI, INC.

City/State/Country

Capitola, CA, US

Establishment Address

908 Sir Francis Ave., Capitola, CA 95010, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ambi Inc. (Owner Number: 10030464)

Owner / Operator Contact Address

908 Sir Francis Ave., Capitola, CA 95010, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cold Pouch Insul-eze auto-Lancet Ambi-Lancet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDQ	N/A	N/A	Class N/A	N/A	2009-10-06
HJF	Magnifier, Hand-Held, Low-Vision	Ophthalmic	Class 1	886.5540	2014-04-03
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2014-04-03

Official Correspondent

Jill Valcarcel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ambi Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K891023	Siemens Medical Electronics	SIEMENS CEILING STAND 800F, 800 AND 810	1989-07-25
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
9616088	Convertors de Mexico S. de R.L. de C.V	CD.JUAREZ Chihuahua, MX
1061124	Sterigenics U.S., LLC	Charlotte, NC, US
1125615	MEDICAL SOLUTIONS, INC.	CHANTILLY, VA, US
3004111573	Sterigenics US LLC	Grand Prairie, TX, US
9610849	Covidien	TIJUANA, B.C. Mexico, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008061617. Last updated year: 2026. Please use registration number 3008061617 when referencing this establishment in official correspondence.